Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate

NCT07892599 | Not Yet Recruiting

• 1 other identifier: RC.5.9.2026
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

Holmium laser enucleation of the prostate (HoLEP) is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release during HoLEP. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for HoLEP at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares continence at 3, 6, and 12 months, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications.

Conditions

Benign Prostatic Hyperplasia; Benign Prostatic Obstruction; Stress Urinary Incontinence; Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Objective Urinary Continence at 1 Month

  Continence defined as zero pad use with no urge incontinence, confirmed by a standardized 1-hour pad test with pad weight gain of 1 g or less. Assessed by a masked outcome assessor

  1 month after surgery

Secondary Outcomes (1)

• Proportion of Participants With Urinary Continence at 3, 6, and 12 Months

  3, 6, and 12 months after surgery

Study Arms (2)

ABP-S-EAR HoLEP

EXPERIMENTAL

Holmium laser enucleation of the prostate with Anterior Bridge-Preserving Semicircular Early Apical Release. Semicircular apical mucosal incisions run from 6 o'clock to 11 o'clock (right) and to 1 o'clock (left). The anterior apical tissue bridge between 11 and 1 o'clock is left intact. Retrograde enucleation and intravesical morcellation follow.

Procedure: Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR)

Conventional EAR HoLEP

ACTIVE COMPARATOR

Holmium laser enucleation of the prostate with conventional early apical release. A continuous circumferential apical mucosal incision through the 12 o'clock position divides the anterior mucosal bridge. Retrograde enucleation and intravesical morcellation follow.

Procedure: Conventional Early Apical Release (EAR)

Interventions

Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR) PROCEDURE

Bipolar Collins knife via 26 Fr continuous-flow resectoscope (120 W cut, 80 W coagulation) for apical and bladder neck incisions. Right incision from 6 o'clock proximal to the verumontanum to 11 o'clock; left from 6 to 1 o'clock. The 11 to 1 o'clock anterior bridge is preserved; dissection at its limits uses the blunt sheath tip without electrocautery. Paired longitudinal incisions from the bladder neck at 11 and 1 o'clock join the apical incisions. Retrograde holmium laser enucleation (550 µm fiber, 2.0 J, 40 Hz) leaves the bridge undisturbed, then mechanical morcellation. Conversion to conventional EAR is allowed if a safe capsular plane cannot be developed.

Also known as: ABP-S-EAR, semicircular early apical release

ABP-S-EAR HoLEP

Conventional Early Apical Release (EAR) PROCEDURE

Same bipolar Collins knife, resectoscope, laser and energy settings, and irrigation as the experimental arm. Continuous circumferential mucosal incision along the proximal border of the external sphincter, through 12 o'clock, completely dividing the anterior mucosal bridge. Retrograde holmium laser enucleation by the standard institutional technique, then intravesical morcellation.

Also known as: Conventional EAR; circumferential early apical release

Conventional EAR HoLEP

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 45 to 80 years.
• Documented symptomatic benign prostatic obstruction (BPO) refractory to medical therapy or with BPO-related complications, with a clinical indication for endoscopic enucleation of the prostate.
• Able to understand the study procedures and give written informed consent.

You may not qualify if:

• Neurogenic bladder dysfunction or major neurological disorder known to impair lower urinary tract function or continence.
• Previous prostate, bladder neck, or urethral surgery that substantially alters apical anatomy.
• Urethral stricture or bladder neck sclerosis requiring concurrent intervention.
• Untreated active urinary tract infection.
• Known or histologically confirmed prostate cancer requiring active oncologic therapy.
• Severe medical condition or any investigator-defined concern that precludes safe anesthesia, surgery, or valid outcome assessment.

Sponsors & Collaborators

• Ahmed Ebrahim Zahran: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon cannot be masked. Participants and independent outcome assessors (follow-up interviews, functional scoring, pad-weight testing) are masked to allocation throughout the study. Allocation is concealed in sequentially numbered, opaque, sealed envelopes opened after induction of anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Urology

Model Details: Prospective, randomized, controlled, parallel-group, single-center trial. Participants are randomized 1:1 to ABP-S-EAR or conventional EAR during holmium laser enucleation of the prostate. One experienced endourologist performs all operations.

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10